Polycystic Ovary Syndrome,NCT01989039
IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women
An observational study of Polycystic Ovary Syndrome, and Insulin Resistance,, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. Read more about this study
- Who is it for?
- Ages 13 to 48 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome,, Insulin Resistance,
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 48 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.
Who may be able to join
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.
Who cannot join
- women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies;
- women who had had menarche less than 1 years before evaluation or who were older than 49;
- women who received hormones or drugs for major medical diseases within three months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan, 116
Ming I Hsu, MD, 886-2-2930-7930 ext. 2508, hsumingi@yahoo.com.tw
About this study
FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.
- Conditions
- Polycystic Ovary Syndrome,, Insulin Resistance,
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women.
Measured: A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome,Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-I Hsu, Taipei Medical University WanFang Hospital
- Investigators
- Ming I Hsu, MD, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989039
- Sponsor's protocol ID
- Hsu2013-TMU-JIRB201307021
- Status last verified
- Nov 2013
- First submitted
- 21 Oct 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Shen SH, Shen SY, Liou TH, Hsu MI, Chang YC, Cheng CY, Hsu CS, Tzeng CR. Obesity and inflammatory biomarkers in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:66-71. doi: 10.1016/j.ejogrb.2015.06.022. Epub 2015 Jul 2.
PubMed 26177495Chen CI, Hsu MI, Lin SH, Chang YC, Hsu CS, Tzeng CR. Adiponectin and leptin in overweight/obese and lean women with polycystic ovary syndrome. Gynecol Endocrinol. 2015 Apr;31(4):264-8. doi: 10.3109/09513590.2014.984676. Epub 2014 Nov 25.
PubMed 25423261
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women
- ClinicalTrials.gov ID
- NCT01989039
- Acronym / sponsor ID
- Hsu2013-TMU-JIRB201307021
- Conditions
- Polycystic Ovary Syndrome,, Insulin Resistance,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.
Key inclusion criteria (1 listed)
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.
Key exclusion criteria (3 listed)
- women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies;
- women who had had menarche less than 1 years before evaluation or who were older than 49;
- women who received hormones or drugs for major medical diseases within three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women.
Time frame: A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Derived from this study: PubMed 26177495Shen SH, Shen SY, Liou TH, Hsu MI, Chang YC, Cheng CY, Hsu CS, Tzeng CR. Obesity and inflammatory biomarkers in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:66-71. doi: 10.1016/j.ejogrb.2015.06.022. Epub 2015 Jul 2.
- Derived from this study: PubMed 25423261Chen CI, Hsu MI, Lin SH, Chang YC, Hsu CS, Tzeng CR. Adiponectin and leptin in overweight/obese and lean women with polycystic ovary syndrome. Gynecol Endocrinol. 2015 Apr;31(4):264-8. doi: 10.3109/09513590.2014.984676. Epub 2014 Nov 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming I Hsu, MD principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, and Insulin Resistance,, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming I Hsu, MD (886-2-2930-7930 ext. 2508, hsumingi@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women. (time frame: A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989039, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.